FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
74761–74784 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 26, 2002
ENDIUS ATAVI SYSTEM
K021748 · HRX
Endius, Inc.
Orthopedic · 29d
Cleared Jun 26, 2002
CEMENTED FEMORAL HEAD RESURFING DEVICE
K021799 · KXA
Biomet Orthopedics, Inc.
Orthopedic · 26d
Cleared Jun 26, 2002
ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER
K021832 · HWC
Biomet, Inc.
Orthopedic · 22d
Cleared Jun 26, 2002
CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM)
K021879 · MNH
Depuyacromed
Orthopedic · 19d
Cleared Jun 26, 2002
CROSSOVER CROSS CONNECTOR (MOSS MIAMI SPINE SYSTEM)
K021880 · MNH
Depuyacromed
Orthopedic · 19d
Cleared Jun 25, 2002
UHI-3 HIGH FLOW INSUFFLATION UNIT
K014166 · HIF
Olympus Optical Co., Ltd.
Obstetrics & Gynecology · 188d
Cleared Jun 25, 2002
ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057
K020296 · EWD
Apothecary Products, Inc.
Ear, Nose, Throat · 148d
Cleared Jun 25, 2002
MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER
K020985 · KNT
Tfx Medical, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 25, 2002
BMN I TYPE MARROW ASPIRATION NEEDLE
K020987 · KNW
H.S. Hospital Service S.R.L.
Gastroenterology & Urology · 90d
Cleared Jun 25, 2002
LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM
K021012 · HDY
Quality Medical Solusions, LLC
Obstetrics & Gynecology · 88d
Cleared Jun 25, 2002
TITANIUM CANNULATED INTERFERENCE SCREW
K021030 · HWC
Future Medical Systems, Inc.
Orthopedic · 88d
Cleared Jun 25, 2002
SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I
K021241 · GKZ
Sysmex Corporation of America
Hematology · 67d
Cleared Jun 25, 2002
MODIFICATION TO PARA 5X
K021922 · JPK
Streck Laboratories, Inc.
Hematology · 14d
Cleared Jun 25, 2002
MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL
K021930 · JJY
Bionostics, Inc.
Chemistry · 13d
Cleared Jun 24, 2002
REPROCESSED EXTERNAL FIXATION DEVICE
K012623 · KTT
Alliance Medical Corp.
Orthopedic · 315d
Cleared Jun 24, 2002
REPROCESSED EXTERNAL FIXATION DEVICE
K012634 · KTW
Alliance Medical, Inc.
Orthopedic · 315d
Cleared Jun 24, 2002
REPROCESSED EBI EXTERNAL FIXATION DEVICES
K012645 · KTW
Alliance Medical Corp.
Orthopedic · 315d
Cleared Jun 24, 2002
REPROCESSED HOWMEDICA EXTERNAL FIXATION DEVICES
K012648 · KTT
Alliance Medical Corp.
Orthopedic · 315d
Cleared Jun 24, 2002
GLUCOPRO EVO INFUSION PUMP
K013309 · LZG
Nipro Diabetes Systems, Inc.
General Hospital · 263d
Cleared Jun 24, 2002
CARDEON AEGIS CATHETER
K013593 · DWF
Cardeon Corp.
Cardiovascular · 237d
Cleared Jun 24, 2002
TANITA BODY COMPOSITION ANALYZER
K014009 · MNW
Tanita Corp. of America
Gastroenterology & Urology · 201d
Cleared Jun 24, 2002
CHOLESTEROL 1, 2, 3
K014018 · LBS
Imi
Chemistry · 200d
Cleared Jun 24, 2002
CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT
K020205 · FRC
Getinge/Castle, Inc.
General Hospital · 153d
Cleared Jun 24, 2002
DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML
K020666 · FMF
Baxter Healthcare Corp
General Hospital · 115d